What Is Oxymorphone?
Oxymorphone is an opioid analgesic 10 times as powerful as morphine that has a controversial history. It originally received FDA approval in 1959 under the name Numorphan but was taken off the market in 1979 due to it being highly abused. Many who abused it said they preferred it to heroin.
Then in 2006, Endo Pharmaceuticals received FDA approval for a newer version called Opana and Opana ER, as immediate release and extended release dosage forms, respectively.
When first re-introduced in 2006, Oxymorphone rapidly gained popularity again. According to IQVIA / IMS Health, the number of prescriptions of oxymorphone went from 268,000 in 2007 to over 1.2 million in 2012! Opana ER (extended release) generated 756,000 prescriptions and sales of $385 million in 2013.
In 2011, the FDA approved an abuse-deterrent version of Opana ER designed to make the drug resistant to physical and chemical manipulation for abuse by snorting and injecting. However, the FDA ruled that the drug did not meet the standard to have language about abuse-deterrent properties on the product label. Endo Pharma tried to block generics on the market by asking to withdraw the original version of Opana ER (i.e., the one without the abuse-deterrent properties) due to safety and effectiveness concerns but the FDA ruled in 2013 that the generics could continue on the market.
Then, in June 2017, after an independent advisory committee voted 18-8 that the benefits no longer outweighed the risks, the FDA asked Endo Pharma to take the reformulated abuse-deterrent version of Opana ER off the market completely which the company did a month later.
Street Names for Oxymorphone include: Blue Heaven, Blues, Mrs. O, New Blues, Octagons, Oranges, Orgasna IR, OM, Pink, Pink Heaven, Pink Lady, Pink O, Stop Signs, and The O Bomb
Oxymorphone is a powerful opioid pain reliever to treat moderate to severe pain. Currently, there are just the Opana branded products and a generic version of oxymorphone from Actavis on the market.
- Opana ER
- Oxymorphone Hydrochloride
Oxymorphone ER is only prescribed for round-the-clock, severe pain relief and in cases where other opiate analgesics are not effective.
Oxymorphone is classified as a schedule II controlled substance under the Federal Controlled Substances Act. It exhibits the same strong addictive, physical dependence, and abuse potential profiles as other schedule II opioid analgesics such as oxycodone and morphine.
Apart from analgesia or pain-relieving effects, other pharmacological effects of the opioid analgesic drug class include:
- Euphoria experiencing a "high"
- Feelings of relaxation
- Calming and anxiety relieving effects
- Respiratory depression
- Myosis or constriction of the pupils
- and in some cases cough suppression
Abrupt discontinuation of oxymorphone and similar schedule II opioids like oxycodone and hydromorphone after extended use can result in the patient experiencing symptoms of opioid withdrawal.
Is Oxymorphone an Opiate or Opioid?
Oxymorphone is a semi-synthetic opioid derived from the naturally occurring substance thebaine harvested from the opium poppy plant and modified in the lab to be commonly used as a pharmaceutical in the form of its salt, oxymorphone hydrochloride. The hydrochloride salt is white or off-white with no smell and dissolves well in water but sparingly in alcohol and other liquids. It is similar to but more potent than morphine with powerful pain-relieving effects. As with other opiate analgesics, it works by attaching to the opioid receptors in the brain and changing the brain's perception of pain. Oxymorphone has similar side effects and withdrawal symptoms to other drugs of the opiate class.
The distinction between an opiate and opioid is whether the entity is derived from a natural source (opium poppy plant) versus synthetically developed to mimic and act like the natural substance but have different chemical structures. Oxymorphone is semi-synthetic because it is a hybrid containing naturally occurring thebaine (from the opium poppy) and synthetic components manufactured in a lab. Hence technically it would be classified as an opioid.
Oxymorphone Side Effects
Oxymorphone side effects include but are not exclusive to:
- Abdominal pain
Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
- Trouble breathing
- Shortness of breath
- Fast heartbeat
- Chest pain
- Swelling of your face, tongue or throat or hands
- Extreme drowsiness
- Light-headedness when changing positions
- Feeling faint
- High body temperature
- Trouble walking
- Stiff muscles
- Mental changes such as confusion
To be taken on an empty stomach, at least 1 hour prior to or 2 hours after eating.
Use of Opana as the first opioid analgesic:
Initiate treatment with Opana in a dosing range of 10 to 20 mg every 4 to 6 hours as needed for pain.Do not initiate treatment with doses higher than 20 mg because of the potential serious adverse reactions.
Source: Opana medication guide found at https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021611s010lbl.pdf#page=25
Use of Opana ER as the first opioid analgesic:
Initiate treatment with Opana ER with the 5 mg tablet orally every 12-hours.
Use of Opana ER in patients who are not Opioid Tolerant
The starting dose for patients who are not opioid tolerant is Opana ER 5 mg orally every 12 hours.
Patients considered opioid tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.
Source: Opana ER medication guide found at:
No one ever wants to find their child, parent, sibling, or friend unconscious and likely from an overdose. Yet, with the opioid epidemic in the US, many of us are having to face this challenge. Whether you are a patient or someone needing to use opioid analgesics for reasons outside of a prescription or a family member of such a person, it is important to be mentally prepared to deal with an opioid overdose, whether it is from oxymorphone, oxycodone, tramadol, fentanyl, morphine or any other opioid analgesic.
Three keys to dealing with an overdose:
- Recognize signs & symptoms of overdose
- Know the treatment for an overdose
- Take steps to prevent overdose
1. Clinical Presentation
First, it’s important to be able to recognize the signs and symptoms of an oxymorphone or other opioid overdose. According to the Opana label on the FDA site, an acute overdose could be recognized from the following:
- Respiratory depression
- Somnolence progressing to stupor or coma
- Skeletal muscle flaccidity
- Cold and clammy skin
- Constricted pupils
2. Treatment of Overdose
Second, it’s important to be able to quickly act, by calling 9-1-1 and treating the overdose to revive the patient until emergency medical personnel can arrive to take over.
To this end, it is critical to keep and know how to use Naloxone, the opioid overdose reversal agent, that is available at retail pharmacies and other centers. Naloxone is widely covered now by co-pays and in many states doesn’t need a prescription to be obtained from a CVS or other pharmacy. Many centers are also giving out Naloxone for free.
Naloxone is an opioid antagonist that works to reverse the effects of oxymorphone and restore breathing and consciousness in the patient. It is available as a nasal spray and an auto-injector with step-by-step directions. If the patient doesn’t respond, a second dose could be administered per the product’s prescribing instructions.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.
3. Preventing an Overdose
Third, being able to take steps to prevent an overdose from occurring at all, which is ideal, but at the least minimizing the chances.
Keys to preventing a oxymorphone overdose
I In the situation where a prescription for oxymorphone is being properly taken:
- Take the medication exactly and only as prescribed
- If you missed a dose, do not double dose and check with the doctor’s office
- Keep medication out of reach of children
- If you or the patient ever feels the underlying pain is not being alleviated or that there is a change in emotional or mental health, talk about it immediately. Call the doctor’s office and alert them and get advice on what to do
- Keep Naloxone on hand and make sure all those around know how to use it
II In the situation where a prescription or illicitly obtained oxymorphone is being misused:
- Get treatment. Contact your doctor or call the SAMHSA National Helpline to get connected with health professionals in your area who can help you. Do not leave the issue unattended, chances are it will just continue and worsen
- Keep a close eye on the individual and seek medical help
- Keep Naloxone on hand and make sure all those around know how to use it
Oxymorphone was available in the 1960s and 1970s and taken off the market due to its high abuse and addiction effects. So, the addiction that could result from using this opioid goes back at least 50 years. The regulatory history of Opana ER is summarized in the linked FDA document reviewed in March, 2017.
Oxymorphone being 10 times as powerful as morphine and easily dissolvable in water can easily be abused and cause addiction. Apart from addiction, following an oxymorphone prescription correctly could cause physical dependence if the drug is taken for a longer period.
With the opioid epidemic and increased regulation of prescriptions for acute pain, with states setting 3 or 7-day limits, the risk of addiction is lowered. However, make sure to always discuss any family members who have had a previous addiction to a substance with your healthcare provider even if they don’t bring it up and options for complementary pain management therapies as well as non-opioid alternatives.
Oxymorphone Withdrawal Symptoms
Oxymorphone withdrawal symptoms include,
- Lacrimation (tearing)
- Rinorrhea (runny nose)
- Myalgia (muscle pain)
- Mydriasis (dilated pupils)
Other signs and symptoms also may develop, including:
- Joint pain
- Abdominal cramps
- Increased blood pressure
- Increased respiratory rate
- Increased heart rate
Oxymorphone withdrawal is very unpleasant and there is a high risk of relapse during detox. Physical withdrawal symptoms last for approximately one week or so but can be prolonged over several weeks/months if you have been taking the drug for a long period of time or in high amounts.
Oxymorphone withdrawal symptoms can be eased by undergoing a medically assisted tapering off regime.
Where Oxymorphone addiction has been identified, a SAMHSA certified opioid treatment program is recommended.
How Long Does Oxymorphone Stay in Your System?
The length of time Oxymorphone stays in your system varies from person to person and is dependent on several personal factors. Body fat percentage, age, metabolism, other medications, general health, and hydration levels can all affect the rate that your body metabolizes and excretes the drug.
Opana half-life ranges from approximately 9-11 hours after a single oral dose (5-40 mg). The time the remaining half can be detected in your system falls within the following time frames, to be used as a broad guideline only:
- Urine: 1-3 days
- Saliva: 12 -24 hours
- Blood: 12 to 24 hours
- Sweat: 1 to 4 weeks
- Hair: 4 to 6 months